Emotion Regulation Therapy for Clinical Worry and Rumination

Not Applicable

Completed

• Conditions: Emotional Dysfunction; Anxiety Disorders and Symptoms; Generalized Anxiety Disorder; Depression, Anxiety

• Registration Number: NCT04060940
• Lead Sponsor: Douglas Mennin

Brief Summary

The present project aims to broaden our understanding of neural mechanisms which may underlie change in symptoms occurring over the course of Emotion Regulation Therapy. Specifically, we aim to examine neural changes as a result of either an 8-session or 16-session version of the treatment.

Detailed Description

This study aims to examine the utility of Emotion Regulation Training (ERT) in reducing symptoms of anxiety and/or depression in young adults aged 18 to 29 years old. Additionally, we are interested in assessing neural, cardiac, and immunological changes associated with psychological symptom reduction in these individuals. Lastly, we are interested in examining whether an abbreviated 8-session version of ERT produces similar results to a longer (16-session) version of ERT.

Study Timeline

• Study Start: 2015-11-06
• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-19
• Primary Completion: 2022-04-26
• Study Completion: 2022-04-26
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-13
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Aged 18-29 years during the time of participation
• Meets diagnostic criteria for an anxiety and/or depressive disorder
• Endorses significant worry and/or rumination

Exclusion Criteria

• Active suicidal intent
• Current substance dependence disorder (within the past year)
• Current or past psychotic disorder, bipolar-I disorder, or dementia
• Not currently received any other form of psychosocial treatment
• Not being on a stabilized dose of medication (less than 3 months) during enrollment
• Pregnancy or plans to become pregnant during active participation
• Irremovable metal objects in the body
• Neurological disorder, traumatic brain injury, or loss of consciousness
• Tattoos if/when posing risks for involvement in the MRI component of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Worry	Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up	Penn State Worry Questionnaire (PSWQ)
Changes in Rumination	Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up	Rumination-Reflection Questionnaire (RRQ)
Changes in Functional Impairment	Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up	Sheehan Disability Scale (SDS)
Changes in Life Satisfaction	Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up	Quality of Life Inventory (QOLI)
Changes in Diagnostic Criteria, Severity, and Improvement	Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up	Structured Clinical Interview for DSM-IV-TR; Clinical Severity Ratings from Anxiety Disorders Interview Schedule, Lifetime version for DSM-IV

Secondary Outcome Measures

Name	Time	Method
Model-Related Changes: Attention Regulation	Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up	Attentional Control Scale (ACS)
Model-Related Changes: Metacognitive Regulation	Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), Weekly for 8- or 16-weeks (depending on version), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up	Experiences Questionnaire (EQ); Emotion Regulation Questionnaire-Reappraisal (ERQ)
Changes in Anxiety and Depression	Pre-Treatment, Mid-Treatment (either 4- or 8- weeks after starting treatment), Post-Treatment (either 8- or 16- weeks after starting treatment), 3-Month Follow-Up, 9-Month Follow-Up, 2-Year Follow-Up	Mood and Anxiety Symptom Questionnaire (MASQ)

Trial Locations

Locations (1)

Teachers College, Columbia University; 🇺🇸 New York, New York, United States